Lean QA - Audit Management

Most pharmaceutical companies have a cGMP auditing program administered at the site and corporate levels of the organization. Given the success seen through the implementation of Lean in QC and Manufacturing, many organizations wish to extend these initiatives to their audit function in order to improve productivity and service level, and lower costs However, faced with a constantly evolving regulatory environment and increasingly varied processes and facility types (manufacturing, warehousing, contractors, suppliers etc.), can Internal Audit functions improve their operational effectiveness while maintaining the same level of regulatory oversight?

Efforts to implement Lean away from the ‘shop floor’ usually focus on elimination of individual wastes, such as excessive documentation or rework, often with the hope that investment in software and infrastructure will provide a platform to improve performance. Unfortunately, these efforts rarely provide significant improvements, as they fail to address the root cause of poor performance – inability to control workload.

A typical audit program, with its mix of routine and ‘for-cause’ audits, and long term annual or semi-annual schedules, is a prime example of a process which pays the penalty associated with a volatile workload. In these programs, failure to control the volume and mix of work creates volatility in the short term, resulting in stressful ‘peaks’ and unproductive ‘troughs’, for both individual auditors and the group as a whole. Attempts at long-term scheduling are counter-productive, and result in near constant rescheduling and reassignment of work. The end product is an audit group with large variation in workload between auditors, extended periods of downtime and significant effort expended by management in dealing with a constantly changing schedule. In the case of a multinational audit group, this also leads to inflated costs associated with travel, due to the inability to effectively utilise local auditors.

The key to transforming these processes is establishing a system that controls the mix and volume of work in the short-interval. By applying BSM’s Real Lean principles – Levelling, Flow & Standard Work – we can control the workload by:

1. Auditing at the Levelled Demand Rate – that is, performing the correct number of audits or ‘audit days’ each month in order to meet the demand.
2. Creating an ordered queue of audit work – allowing the group to ensure that the highest priority audits are completed first.

Auditing at the ‘Levelled Demand Rate’ allows for control over volume and mix of workload – releasing the same amount of audit work each month. Queuing ensures that the highest priority audits are selected and scheduled. Rather than using ‘target dates’ for audits, a risk-based queue for prioritisation (using a Risk Prioritisation Number) ensures the highest priority work is always selected and also limits the impact of ad-hoc audits. This eliminates the need for ineffective ‘fast-track’ systems, improving compliance within a Quality Risk Management (QRM) framework. Because the group’s workload is prioritised based on risk, rather than arbitrary ‘due-dates’, the highest priority audits are always carried out first.

Using a shorter planning window for confirmed audits, problems associated with poor schedule reliability can be resolved. This eliminates the need for complex re-scheduling and reassignment processes. It also creates the opportunity to control the selection of audits to create productive audit trips that minimise travel costs and maintain productivity.

BSM have shown that the proper application of the principles of levelling, flow and standard work will create a truly Lean audit group, better placed to reliably and productively meet their customer demands. They can achieve this without the need for complex prioritization systems or excessive re-scheduling effort, with lower costs and less stress for auditors and the scheduling function alike.